Regulatory
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The FDA has approved Alembic Pharmaceuticals’ ANDA for its formoterol fumarate inhalation solution, a generic of Mylan’s Perforomist inhalation solution for the treatment of COPD, the company said. According to the announcement, this is the… Read more . . .
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Janssen Pharmaceutical announced that it has launched Spravato esketamine nasal spray in Australia for the treatment of treatment-resistant depression following approval by the TGA. The company also said that will file a submission to the… Read more . . .
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According to Tonix Pharmaceuticals, the FDA has cleared the company’s IND for a Phase 2 study of TNX-1900 potentiated oxytocin nasal spray for the prevention of migraine headache. Tonix acquired the rights to the intranasal… Read more . . .
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Padagis (formerly Perrigo’s generic prescription pharmaceutical business) has announced the launch of its generic version of Zomig zolmitriptan nasal spray for the treatment of migraine headaches in patients aged 12 and older. Altaris acquired Padagis… Read more . . .
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According to Liquidia, the FDA has tentatively approved the company’s NDA for its Yutrepia (LIQ861) treprostinil DPI for the treatment of pulmonary arterial hypertension (PAH). The FDA had previously issued a complete response letter to… Read more . . .
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According to EffRx Pharmaceuticals, Swissmedic has approved Bronchitol inhaled dry powder mannitol as an add-on to other medications for the treatment of cystic fibrosis in patients 6 years old and older. EffRx acquired Swiss rights… Read more . . .
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According to TFF Pharmaceuticals, Health Canada has issued a no objection letter regarding a Phase 1 clinical trial of TFF’s dry powder inhaled niclosamide that will evaluate 0.5, 2, and 6 mg doses in healthy volunteers… Read more . . .
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United Therapeutics said that the FDA has issued a complete response letter regarding the company’s NDA for Tyvaso treprostinil DPI for the treatment of pulmonary arterial hypertension (PAH) and pulmonary hypertension associated with interstitial lung… Read more . . .
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According to Oyster Point Pharma, the FDA has approved the company’s Tyrvaya (OC-01) varenicline nasal spray for the treatment of dry eye disease, and Oyster Point expects to launch the nasal spray in November 2021.… Read more . . .
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Bayer HealthCare and Meda Pharmaceuticals have filed a patent infringement suit against Apotex after Apotex submitted an ANDA for a generic version of Astepro Allergy azelastine hydrochloride nasal spray, 0.15%. The FDA approved Bayer’s NDA… Read more . . .
Upcoming Events
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May 10-May 14: RDD 2026, Phoenix, AZ, USA
May 15-May 16: ATS Respiratory Innovation Summit 2026, Orlando, FL, USA
May 17-May 20: ATS International Conference 2026, Orlando, FL, USA
June 10: SMI.London 2026, London, UK
July 13-July 16: 2026 ISAM Congress, Taipei, Taiwan